METHODS: In this double-blind prospective randomized trial, patients from 13 hospitals, who were diagnosed with venous incompetence by duplex ultrasound and classified as clinical class 1, 2, or 3 in the Clinical, Etiological, Anatomical, and Pathophysiological classifications were enrolled. The primary outcome was the change in the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20) score at 8 weeks from baseline. Secondary outcomes included changes in the Aberdeen Varicose Vein Questionnaire, visual analog scale, and Venous Clinical Severity Score at 4 and 8 weeks from baseline. Moreover, the change in leg circumferences was measured at 8 weeks and compared to baseline.
RESULTS: In total, 303 patients were enrolled and randomly assigned to receive either Vitis vinifera seed extract (n = 154) or MPFF (n = 149). The CIVIQ-20 scores at 8 weeks were significantly reduced compared to those at baseline in both groups. No significant intergroup difference in the change of CIVIQ-20 at 8 weeks from baseline was observed (-8.31 ± 14.63 vs. -10.35 ± 14.38, P = 0.29, 95% confidence interval -1.65 to 5.72). The lower limit of the 95% confidence interval was within the predefined noninferiority margin of 6.9. Furthermore, the Aberdeen Varicose Vein Questionnaire, visual analog scale, and Venous Clinical Severity Score scores significantly decreased at 4 and 8 weeks after randomization compared with baseline in both groups. No significant differences were observed in the reduction of each score between groups. The calf circumference measured at 8 weeks was significantly reduced compared to that at baseline in patients receiving Vitis vinifera seed extract.
CONCLUSIONS: Vitis vinifera seed extract was noninferior to MPFF in relieving venous symptoms and improving the quality of life in patients with chronic venous disease.
方法:在这项双盲前瞻性随机试验中,13家医院的病人,通过双工超声诊断为静脉功能不全,并在临床中将其分类为临床1、2或3级,病因学,解剖学,并纳入病理生理学分类。主要结果是慢性静脉疾病生活质量问卷(CIVIQ-20)评分在8周时从基线的变化。次要结局包括阿伯丁静脉曲张问卷(AVVQ)的变化,视觉模拟量表(VAS),和静脉临床严重程度评分(VCSS)在4周和8周从基线。此外,在第8周时测量了腿围的变化,并与基线进行了比较.
结果:总计,纳入303名患者,并随机分配接受葡萄种子提取物(n=154)或MPFF(n=149)。与基线相比,两组在8周时的CIVIQ-20评分均显着降低。从基线开始8周时,CIVIQ-20的变化在组间没有显着差异(-8.31±14.63vs.-10.35±14.38,P=0.29,95%置信区间[CI]-1.65至5.72)。95%CI的下限在6.9的预定义非劣效性范围内。此外,AVVQ,VAS,与基线相比,两组在随机分组后4周和8周VCSS评分均显著下降。组间各评分的降低没有观察到显著差异。与接受葡萄种子提取物的患者的基线相比,在8周时测量的小腿周长显着降低。
结论:葡萄籽提取物在缓解静脉症状和改善CVD患者生活质量方面不劣于MPFF。